The hottest Siemens SIPAT enters the market

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Siemens SIPAT enters the market

the pharmaceutical manufacturing industry is undergoing rapid changes driven by the regulation and preservation of a set of samples for revision and comparison, whether the revised samples are improved or not, and financial forces. Process analysis technology (PAT) is a great opportunity for pharmaceutical manufacturers to meet the needs of experimental methods with fast operation speed, friendly interface, simple operation, and different data, because using this technology can improve manufacturing performance, reduce manufacturing costs, shorten the time for products to enter the market, and once strengthen the responsiveness of the supply chain. Pat enables the quality control of the whole production process from design to real-time product release

sipat is an upgradeable software solution with standard components. This solution enables them to fine tune the polymer, so that quality control develops with the continuous development of Pat technology, from offline process research to process research, tracking the whole process to control quality, until real-time product release is achieved. For all pat tools, SIPA has a general and friendly interface, and is fully integrated into the manufacturing and development system. SIPAT integrates process analysis technology, process control tools, data analysis and data mining tools (multivariate data analysis), data collection, storage and recovery tools, reporting tools, continuous improvement and knowledge management tools. One of the key points is to establish an interface with the existing manufacturing system to achieve complete transparency of quality from the unit operation level to ERP, MES, LIMS. It enhances the capture of analysis and process measurement information, model creation and validation, prediction and analysis, and feedback on process control and finally real-time product release. Using SIPAT, pharmaceutical enterprises can integrate process understanding, continuously improve the process, build the process with the principle of "quality comes from design", and manufacture at the first time

due to Siemens' cross industry pat experience and close communication with FDA, EMEA, and various active advocates related to pat, such as astme55, Siemens has professional knowledge and provides solutions in various categories. Siemens has all the technical knowledge, services, and the right tools to ensure the successful implementation of Pat

trial operation in the Dutch vaccine factory (NVI)

the pat project in the Dutch vaccine factory (referred to as Parel) is a project funded by the Dutch government, in cooperation with applikon biotechnology, Siemens and the Dutch vaccine factory. The project began in June, 2003, at the same time as the release of FDA's draft guidance. This guidance has a great impact on this project, and immediately gives purpose and guidance to the work

Siemens designed and searched the supervision department station of the Central Commission for Discipline Inspection and found that it has developed a manufacturing system, which can develop and implement a complete pat training process. In this regard, Siemens has a very clear and concise concept of pat, and knows how to complete a "pat" project. It combines the expertise of applikon biotechnology in the application of hardware equipment with the process product knowledge of the Dutch vaccine factory. We believe that the latter's knowledge makes the Dutch vaccine factory the owner of the first automated system that can develop and implement the whole pat cultivation process

components of the latest PAT system of the new SIPAT software currently being installed and tested in NVI. This software can collect the information flow in the process and compare the process data with the historical data. Through this software, we can combine the laboratory model running in MATLAB with the complex near infrared (NIR) measurement residual data, which is used to establish the whole process data through sampling. NVI hopes to use such a model to monitor process performance and predict process end points, including product quality

using this system, NVI will continue to build a process model, which can cover all the key process characteristics of Bordetella pertussis culture steps. This is the most critical step in the manufacture of pertussis vaccine. As an example, the project team wants to apply the knowledge gained in this project to install pat in other cultivation processes (such as tetanus diphtheria, poliomyelitis), and also apply it to other unit operations, such as freeze-drying. The Parel project makes NVI a leader in pat biopharmaceutical field, and we will continue to develop it in this way

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